N.D. Admin. Code 33.1-10-15-06

Current through Supplement No. 394, October, 2024

Section 33.1-10-15-06 - Therapeutic radiation machines of less than five hundred kilovolts

1. Leakage radiation. When the x-ray tube is operated at its maximum rated tube current for the maximum kilovolts, the leakage air kerma rate shall not exceed the value specified at the distance specified for that classification of therapeutic radiation machine:

a. Five to fifty kilovolts systems. The leakage air kerma rate measured at any position five centimeters from the tube housing assembly shall not exceed one milligray (100 mrad) in any one hour.

b. Greater than fifty and less than five hundred kilovolts systems. The leakage air kerma rate measured at a distance of one meter from the target in any direction shall not exceed one centigray (1 rad) in any one hour. This air kerma rate measurement may be averaged over areas no larger than one hundred square centimeters. In addition, the air kerma rate at a distance of five centimeters from the surface of the tube housing assembly shall not exceed thirty centagray (30 rad) per hour.

c. For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in subdivisions a and b for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the installation for inspection by the department.

2. Permanent beam-limiting devices. Permanent diaphragms or cones used for limiting the useful beam shall provide at least the same degree of attenuation as required for the tube housing assembly.

3. Adjustable or removable beam-limiting devices.

a. All adjustable or removable beam-limiting devices, diaphragms, cones, or blocks shall not transmit more than five percent of the useful beam for the most penetrating beam used; and

b. When adjustable beam-limiting devices are used, the position and shape of the radiation field shall be indicated by a light beam.

4. Filter system. The filter system shall be so designed that:

a. Filters cannot be accidentally displaced at any possible tube orientation;

b. An interlock system prevents irradiation if the proper filter is not in place;

c. The air kerma rate escaping from the filter slot shall not exceed one centigray (1 rad) per hour at one meter under any operating conditions; and

d. Each filter shall be marked as to its material of construction and its thickness. For wedge filters, the nominal wedge angle shall appear on the wedge or wedge tray, if permanently mounted to the tray.

5. Tube immobilization.

a. The x-ray tube shall be so mounted that it cannot accidentally turn or slide with respect to the housing aperture; and

b. The tube housing assembly shall be capable of being immobilized for stationary portal treatments.

6. Source marking. The tube housing assembly shall be so marked that it is possible to determine the location of the source to within five millimeters, and such marking shall be readily accessible for use during calibration procedures.

7. Beam block. Contact therapy tube housing assemblies shall have a removable shield of material, equivalent in attenuation to five-tenths millimeters of lead at one hundred kilovolts, which can be positioned over the entire useful beam exit port during periods when the beam is not in use.

8. Timer. A suitable irradiation control device shall be provided to terminate the irradiation after a preset time interval.

a. A timer with a display shall be provided at the treatment control panel. The timer shall have a preset time selector and an elapsed time or time remaining indicator;

b. The timer shall be a cumulative timer that activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator;

c. The timer shall terminate irradiation when a preselected time has elapsed, if any dose-monitoring system present has not previously terminated irradiation;

d. The timer shall permit accurate presetting and determination of exposure times as short as one second;

e. The timer shall not permit an exposure if set at zero;

f. The timer shall not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and

g. Timer shall be accurate to within one percent of the selected value or one second, whichever is greater.

9. Control panel functions. The control panel, in addition to the displays required by other provisions in this section, shall have:

a. An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;

b. An indication of whether x-rays are being produced;

c. A means for indicating x-ray tube potential and current;

d. The means for terminating an exposure at any time;

e. A locking device which will prevent unauthorized use of the therapeutic radiation machine; and

f. A positive display of specific filters in the beam.

10. Multiple tubes. When a control panel may energize more than one x-ray tube:

a. It shall be possible to activate only one x-ray tube at any time;

b. There shall be an indication at the control panel identifying which x-ray tube is activated; and

c. There shall be an indication at the tube housing assembly when that tube is energized.

11. Target-to-skin distance (TSD). There shall be a means of determining the central axis target-to-skin distance to within one centimeter and of reproducing this measurement to within two millimeters thereafter.

12. Shutters. Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five seconds after the x-ray "ON" switch is energized, the beam shall be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter shall be controlled by the operator from the control panel. An indication of shutter position shall appear at the control panel.

13. Low filtration x-ray tubes. Each therapeutic radiation machine equipped with a beryllium or other low-filtration window shall be clearly labeled as such upon the tube housing assembly and shall be provided with a permanent warning device on the control panel that is activated when no additional filtration is present, to indicate that the dose rate is very high.

14. Facility design requirements for therapeutic radiation machines capable of operating in the range fifty kilovolts to five hundred kilovolts. In addition to shielding adequate to meet requirements of section 33.1-10-15-09, the treatment room shall meet the following design requirements:

a. Aural communication. Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel.

b. Viewing systems. Provision shall be made to permit continuous observation of the patient during irradiation and the viewing system shall be so located that the operator can observe the patient from the control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational.

15. Additional requirements. Treatment rooms that contain a therapeutic radiation machine capable of operating above one hundred fifty kilovolts shall meet the following additional requirements:

a. All protective barriers shall be fixed except for entrance doors or beam interceptors;

b. The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room;

c. Interlocks shall be provided such that all entrance doors, including doors to any interior booths, shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel; and

d. When any door referred to in subdivision c is opened while the x-ray tube is activated, the air kerma rate at a distance of one meter from the source shall be reduced to less than one milligray (100 mrad) per hour.

16. Full calibration measurements.

a. Full calibration of a therapeutic radiation machine subject to this section shall be performed by, or under the direct supervision of, a radiation therapy physicist:

(1) Before the first medical use following installation or reinstallation of the therapeutic radiation machine;

(2) At intervals not exceeding one year; and

(3) Before medical use under the following conditions:

(a) Whenever quality assurance check measurements indicate that the radiation output differs by more than five percent from the value obtained at the last full calibration and the difference cannot be reconciled; and

(b) Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.

(4) Notwithstanding the requirements of paragraph 3:

(a) Full calibration of therapeutic radiation machines with multi-energy capabilities is required only for those modes or energies, or both, that are not within their acceptable range; and

(b) If the repair, replacement, or modification does not affect all energies, full calibration shall be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in subparagraph a of paragraph 3.

b. To satisfy the requirement of subdivision a, full calibration shall include all measurements recommended for annual calibration by NCRP report 69, "dosimetry of x-ray and gamma ray beams for radiation therapy in the energy range ten keV to fifty MeV" (1981).

c. The registrant shall maintain a record of each calibration for the duration of the registration. The record shall include the date of the calibration; the manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the x-ray tube; the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and the signature of the radiation therapy physicist responsible for performing the calibration.

17. Periodic quality assurance checks.

a. Periodic quality assurance checks shall be performed on therapeutic radiation machines subject to this section, which are capable of operation at greater than or equal to fifty kilovolts.

b. To satisfy the requirement of subdivision a, quality assurance checks shall meet the following requirements:

(1) The registrant shall perform quality assurance checks in accordance with written procedures established by the radiation therapy physicist; and

(2) The quality assurance check procedures shall specify the frequency at which tests or measurements are to be performed. The quality assurance check procedures shall specify that the quality assurance check shall be performed during the calibration specified in subdivision a of subsection 16. The acceptable tolerance for each parameter measured in the quality assurance check, when compared to the value for that parameter determined in the calibration specified in subdivision a of subsection 16, shall be stated.

c. The cause for a parameter exceeding a tolerance set by the radiation therapy physicist shall be investigated and corrected before the system is used for patient irradiation.

d. Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the radiation therapy physicist's quality assurance check procedures, the system shall be recalibrated as required in subdivision a of subsection 16.

e. The registrant shall use the dosimetry system described in subdivision b of subsection 3 of section 33.1-10-15-04 to make the quality assurance check required in subdivision b.

f. The registrant shall have the radiation therapy physicist review and sign the results of each radiation output quality assurance check within one month of the date that the check was performed.

g. The registrant shall ensure that safety quality assurance checks of therapeutic radiation machines subject to section 33.1-10-15-06 are performed at intervals not to exceed one month.

h. Notwithstanding the requirements of subdivisions f and g, the registrant shall ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by subdivisions f and g have been performed within the thirty-day period immediately prior to said administration.

i. To satisfy the requirement of subdivision g, safety quality assurance checks shall ensure proper operation of:

(1) Electrical interlocks at each external beam radiation therapy room entrance;

(2) The "BEAM-ON" and termination switches;

(3) Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;

(4) Viewing systems; and

(5) If applicable, electrically operated treatment room doors from inside and outside the treatment room.

j. The registrant shall maintain a record of each quality assurance check required by subdivision g for three years. The record shall include the date of the quality assurance check; the manufacturer's name, model number, and serial number of the therapeutic radiation machine; the manufacturer's name, model number, and serial number for the instruments used to measure the radiation output of the therapeutic radiation machine; and the signature of the individual who performed the periodic quality assurance check.

18. Operating procedures.

a. The therapeutic radiation machine shall not be used for irradiation of patients unless the requirements of subsection 16 of section 33.1-10-15-06 and subsection 17 of this section have been met;

b. Therapeutic radiation machines shall not be left unattended unless secured pursuant to subdivision e of subsection 9;

c. When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used;

d. The tube housing assembly shall not be held by an individual during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed fifty kilovolts. In such cases, the holder shall wear protective gloves and apron of not less than five-tenths millimeters lead equivalency at one hundred kilovolts;

e. A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console; and

f. No individual other than the patient shall be in the treatment room during exposures from therapeutic radiation machines operating above one hundred fifty kilovolts. At energies less than or equal to one hundred fifty kilovolts, any individual, other than the patient, in the treatment room shall be protected by a barrier sufficient to meet the requirements of 33.1-10-04.2-01 [ 10 CFR 20.1201 ].

19. Possession of survey instruments. Each facility location authorized to use a therapeutic radiation machine in accordance with this section shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range ten microsievert (1 mrem) per hour to ten millisievert (1,000 mrem) per hour. The survey instruments shall be operable and calibrated in accordance with section 33.1-10-15-08.

N.D. Admin Code 33.1-10-15-06

Adopted by Administrative Rules Supplement 370, October 2018, effective 1/1/2019.

General Authority: NDCC 23.1-03-02; S.L. 2017, ch. 199, § 1

Law Implemented: NDCC 23.1-03-03; S.L. 2017, ch. 199, § 18